Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650

Avigen

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: AV650

Study type: Interventional

Funder types: Industry

Identifiers

NCT00364039

AV650-012

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-smoking
• Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage

Exclusion criteria

• Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS)
• History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease
• History of HIV or Hepatitis B
• History of symptomatic hypotension
• History of mental illness, drug addiction, drug abuse or alcoholism
• History of cancer
• History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis)
• Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids
• History of gastric or duodenal ulcer disease
• History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1
• Female subjects who are pregnant or nursing
• Have donated blood within 90 days of Study Day -1
• Have received an investigational drug within 90 days of Screening
• Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1